drugset / Trial / NCT00441701

Study to Evaluate the Safety and Dose-Range of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (MK-7123-012)

NCT00441701

Phase 2 Terminated 99 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a two-part study conducted at multiple centers, of navarixin (SCH 527123, MK-7123) in participants with moderate to severe chronic obstructive pulmonary disease (COPD). Part 1 of the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of four treatment groups enrolled in three cohorts. The duration of treatment, for each cohort, will be a 2-week run-in period, followed by a 12-week double-blind treatment period. Treatment initiation for each cohort was staggered by 4 weeks to allow for safety assessment prior to use of higher doses of navarixin. Part 2 of the study will be a double-blind, placebo-controlled, randomized, parallel group study consisting of four treatment groups enrolled as one cohort. The duration of treatment will consist of a 2-week run-in period, followed by a 12-week double-blind treatment period.

Timeline

Start
2006-12-01
Primary completion
2008-10-01
Completion
2008-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject NAVARIXIN ANHYDROUS Small molecule 3 mg
Subject NAVARIXIN ANHYDROUS Small molecule 10 mg
Subject NAVARIXIN ANHYDROUS Small molecule 30 mg
Background Salbutamol Unknown